Wound treatment apparatuses and methods with negative pressure source integrated into wound dressing

ABSTRACT

Disclosed embodiments relate to apparatuses and methods for wound treatment. In some embodiments, a negative pressure source is incorporated into a wound dressing apparatus so that the wound dressing and the negative pressure source are part of an integral or integrated wound dressing structure that applies the wound dressing and the negative pressure source simultaneously to a patient&#39;s wound. The negative pressure source and/or electronic components may be positioned between a wound contact layer and a cover layer of the wound dressing. The negative pressure source and/or electronic components may be separated and/or partitioned from an absorbent area of the dressing. A switch may be integrated with the wound dressing to control operation of the wound dressing apparatus. A connector may be direct air from an outlet of the negative pressure source to the environment. A non-return valve may inhibit back flow of air into the wound dressing.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.62/304,790, filed Mar. 7, 2016, U.S. Provisional Application No.62/305,926, filed Mar. 9, 2016, U.S. Provisional Application No.62/304,910, filed Mar. 7, 2016, and U.S. Provisional Application No.62/327,537, filed Apr. 26, 2016, the entireties of each of which arehereby incorporated by reference.

BACKGROUND Technical Field

Embodiments described herein relate to apparatuses, systems, and methodsthe treatment of wounds, for example using dressings in combination withnegative pressure wound therapy.

Description of the Related Art

Prior art dressings for use in negative pressure have included anegative pressure source located in a remote location form the wounddressing. Further, when used, wound exudate may soak into the dressing,and the moisture from the wound has made it difficult to incorporateelectronic components into the dressing.

SUMMARY

Embodiments of the present disclosure relate to apparatuses and methodsfor wound treatment. Some of the wound treatment apparatuses describedherein comprise a negative pressure source or a pump system forproviding negative pressure to a wound. Wound treatment apparatuses mayalso comprise wound dressings that may be used in combination with thenegative pressure sources and pump assemblies described herein. In someembodiments, a negative pressure source is incorporated into a wounddressing apparatus so that the wound dressing and the negative pressuresource are part of an integral or integrated wound dressing structurethat applies the wound dressing and the negative pressure sourcesimultaneously to a patient's wound. The negative pressure source and/orelectronic components may be positioned between a wound contact layerand a cover layer of the wound dressing. The negative pressure sourceand/or electronic components may be separated and/or partitioned from anabsorbent area of the dressing. A switch may be integrated with thewound dressing to control operation of the wound dressing apparatus. Aconnector may be direct air from an outlet of the negative pressuresource to the environment. A non-return valve may inhibit back flow ofair into the wound dressing. These and other embodiments as describedherein are directed to overcoming particular challenges involved withincorporating a negative pressure source and/or electronic componentsinto a wound dressing.

In some aspects, a wound dressing apparatus comprises a wound contactlayer configured to be positioned in contact with a wound, a first areaover the wound contact layer comprises a lower spacer layer and anabsorbent layer, a second area over the wound contact layer comprising aplurality of spacer layers and a negative pressure source and/orelectronic components positioned within or between the plurality ofspacer layers, wherein the first area is positioned adjacent to thesecond area and separated by a partition, an upper spacer layerconfigured to cover the first area and the second area and to allow airto be communicated between the first area and second area around thepartition, and a cover layer configured to cover and form a seal overthe wound contact layer, the upper spacer layer, the first area, and thesecond area.

The apparatus of the preceding paragraph may also include anycombination of the following features described in this paragraph, amongothers described herein. The plurality of spacer layers in the secondarea can include a third spacer layer beneath the negative pressuresource and/or electronic components and a fourth spacer layer positionedabove the negative pressure source and/or electronic components, whereinthe fourth spacer layer comprises one or more cutouts or recessesconfigured to receive the negative pressure source and/or electroniccomponents. The partition can include a non-porous dam. The apparatuscan comprise one or more user interface components configured to allow auser to operate the negative pressure source and/or electroniccomponents.

In some aspects, a wound dressing apparatus can comprise a wounddressing configured to be positioned over a wound site, a negativepressure source disposed on or positioned within the wound dressing, anda switch integrated with the wound dressing configured to controloperation of the wound dressing apparatus.

The apparatus of the preceding paragraph may also include anycombination of the following features described in this paragraph, amongothers described herein. The switch can be at least one of positionedwithin, disposed on, or embedded in the wound dressing. The wounddressing can comprise a wound dressing body and a wound dressing border,the wound dressing border extending along at least of a portion of aperimeter defined around the wound dressing body. The switch can beintegrated with the wound dressing body or the wound dressing border.The switch can be at least one of positioned within, disposed on, orembedded in the wound dressing body or the wound dressing border. Thewound dressing body and the wound dressing border can comprise a toplayer and a bottom layer, the top layer comprising a cover layer and thebottom layer comprising a wound contact layer, the switch beingintegrated with the wound dressing proximally adjacent at least one ofthe top layer and the bottom layer. The wound dressing body or the wounddressing border can comprise a flexiboard layer beneath the switch todissipate and/or inhibit the transfer of a compression force to thewound site when the switch is actuated. The switch can be configured tobe actuated by pressing the switch in a first direction with a finger.The wound dressing can comprise a tab that extends from the wounddressing border, the switch being integrated with the tab. The switchcan be at least one of positioned within, disposed on, or embedded inthe tab. The tab can be configured to be lifted by a user so that theswitch can be actuated by the user by applying force to the switch intwo opposing directions on opposite or different sides of the tab. Thewound dressing can comprise a joint between the tab and the wounddressing border to facilitate movement of the tab without applying forceto the wound dressing body or the wound dressing border, the tab beingconfigured to rotate about the joint when a user moves the tab. Theapparatus can include one or more indicators configured to indicate oneor more statuses of the wound dressing apparatus. The one or moreindicators can comprise one or more visual indicators. The one or morevisual indicators can comprise one or more light emitting diodes (LEDs).The one or more indicators can be configured to indicate a battery levelof the wound dressing apparatus. The one or more indicators can extendaround the switch. The one or more indicators can circumferentiallyextend around the switch. The switch can be positioned in a sub-flushposition relative to the one or more indicators to inhibit accidental orinadvertent actuation of the switch. The switch can be selectivelyoperable by a user to control operation of the negative pressure source.The switch can be selectively operable by a user to turn on and turn offthe negative pressure source. The switch can be electrically connectedto the negative pressure source. The negative pressure source can be amicro pump.

In some aspects, a wound dressing apparatus can comprise a wounddressing configured to be positioned over a wound site, a negativepressure source disposed on or positioned within the wound dressing, thenegative pressure source comprising an inlet and an outlet, the negativepressure source being configured to apply negative pressure to the woundsite via the inlet and being further configured to remove air from thewound dressing via the outlet, and a connector comprising first andsecond ends and a flow path therebetween, wherein the first end is influid communication with the outlet and the second end is open to anenvironment outside the wound dressing, wherein a portion of the flowpath extends through an opening defined in the wound dressing, the flowpath being configured to direct air from the outlet to the environment.

The apparatus of the preceding paragraph may also include anycombination of the following features described in this paragraph, amongothers described herein. The opening in the wound dressing can bedefined on a top layer of the wound dressing. The top layer can comprisea moisture vapor permeable film. The opening in the wound dressing canbe defined between a top layer and a bottom layer of the wound dressing.The opening in the wound dressing can be defined through an edge of thewound dressing between a top layer and a bottom layer of the wounddressing. The top layer can comprise a moisture vapor permeable film andthe bottom layer comprises a wound contact layer. The connector cancomprise a spacer that extends between a first and second portion of theconnector, the spacer being configured to resist collapse of theconnector when the connector is compressed. The first and secondportions of the connector can comprise the first and second ends of theconnector. The spacer can be enveloped in a film to form a gas tightseal with the wound dressing. The spacer can comprise a length of 3Dfabric material. The film can be a plastic film. The film can beVersapore film having a pore size diameter of about 2 μm. The connectorcan form a gas tight seal with the wound dressing. The connector canform a gas tight seal with the outlet of the negative pressure source.The connector can be configured to resist collapse, thereby inhibitingocclusion of the connector when the wound dressing is subjected tocompressive forces. The connector can be configured to inhibit theingress of water, foreign bodies, dirt, or bacteria through the openingin the wound dressing. The wound dressing apparatus further can comprisea tube interposed between the outlet and the connector, the tube beingcoupled to the outlet and the connector. The tube can be configured toextend the connector such that the connector is positioned outside ofthe wound dressing after the tube passes through the opening in thewound dressing.

In some aspects, a wound dressing apparatus can comprise a wounddressing configured to be positioned over a wound site, a negativepressure source disposed on or positioned within the wound dressing, thenegative pressure source comprising an inlet and an outlet and beingoperable to apply negative pressure to the wound site, and a non-returnvalve in fluid communication with the outlet, the non-return valve beingconfigured to inhibit back flow of air into the wound dressing.

The apparatus of the preceding paragraph may also include anycombination of the following features described in this paragraph, amongothers described herein. The non-return valve can be configured toinhibit back flow of air into the wound dressing through the outlet. Thenon-return valve can be connected to the outlet. The non-return valvecan comprise a first end in fluidic communication with the outlet and asecond end in fluid communication with an exhaust component, the exhaustcomponent being configured to direct air from the outlet to theenvironment. The first end of the non-return valve can be connected tothe outlet and the second end of the non-return valve is connected tothe exhaust component. The non-return valve is at least partiallydisposed in the outlet. The apparatus can include an exhaust systemhaving first and second ends, wherein the exhaust system is interposedbetween the outlet and the non-return valve such that the first end isconnected to the outlet and the second end is connected to thenon-return valve. The apparatus can include an exhaust system, whereinthe non-return valve is at least partially integrated with the exhaustsystem. The non-return valve can be at least partially integrated withthe exhaust system at an end of the exhaust system. The non-return valvecan be integrated with the wound dressing. The non-return valve can bepositioned within and/or embedded in the wound dressing. The non-returnvalve can comprise a size configured to fit within the wound dressing.The non-return valve can have a height that is less than a thickness ofthe wound dressing. The non-return valve can have a low crackingpressure and a low resistance to out flow. The non-return valve can havea cracking pressure of less than 500 Pa for a nominal flow rate of about1 mL/min through the apparatus. The non-return valve can have an outflow resistance of less than 30 mL/min as measured with a nominallyfixed vacuum of 10.7 kPa below atmosphere. The non-return valve canprovide a resistance to air flowing out of the wound dressing apparatusof less than 100 mL/min as measured with a nominally fixed vacuum of10.7 kPa below atmosphere. The negative pressure source and thenon-return valve together can allow air to leak into the wound dressingapparatus via the outlet at a negligible rate of less than 2.0 mL/min.The non-return valve can be a mechanical valve that is self-activated.The non-return valve can comprise a duckbill valve. The non-return valvecan comprise a reed valve. The reed valve can comprise a 75 micron thickpolyester reed valve. The non-return valve can comprise a cavity with aninlet port and an outlet port and a reed at least partially disposed inthe cavity. The non-return valve can comprise a crescent shape. Thecrescent shape can be defined by a housing having a first curved surfacethat intersects a second surface. The second surface can be flat. Thesecond surface can be curved, the second surface can have a radius ofcurvature that is greater than a radius of curvature of the first curvedsurface. The second surface can be semi-rigid or flexible such that itis configured to conform to a surface of the wound site. The non-returnvalve can comprise a crescent shape, wherein the reed can comprise arectangular shape with circular ends. The non-return valve can comprisea crescent shape, wherein the reed can include a curved portion. Thenegative pressure source can be a micro pump. The apparatus can includea controller configured to control the operation of the micro pump toapply negative pressure to the wound site.

Any of the features, components, or details of any of the arrangementsor embodiments disclosed in this application, including withoutlimitation any of the pump embodiments and any of the negative pressurewound therapy embodiments disclosed below, are interchangeablycombinable with any other features, components, or details of any of thearrangements or embodiments disclosed herein to form new arrangementsand embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure will now be described hereinafter,by way of example only, with reference to the accompanying drawings inwhich:

FIG. 1 illustrates an embodiment of a topical negative pressure woundtreatment apparatus comprising a wound dressing in combination with apump;

FIG. 2 illustrates an embodiment of a source of negative pressure andbattery integrated on top of a dressing layer;

FIG. 3 illustrates an embodiment of layers of a wound dressing withintegrated pump and electronic components;

FIG. 4 illustrates an embodiment of a cross-section of an integratedwound dressing;

FIG. 5 illustrates an embodiment of a cross-section of an integratedwound dressing with ultrasonic oscillation;

FIGS. 6A-6D illustrates embodiments of a pump pouch or pockets accordingto some embodiments;

FIG. 7 illustrates an embodiment of a pressure fuse that can be used todiscontinue operation of the pump if the pressure exceeds an acceptable(or safe) threshold pressure;

FIG. 8 illustrates an embodiment of an integrated wound dressing withthe pump and electronics package incorporated within the dressing;

FIGS. 9A-9B illustrate another embodiment of an integrated wounddressing;

FIG. 10 illustrates a close up view of one end of an embodiment of anintegrated wound dressing;

FIG. 11A shows a top view of an embodiment of a wound dressing where thepump and associated components are visible;

FIG. 11B shows a bottom view of an embodiment of a wound dressing whererecesses for the pump and associated components are visible;

FIGS. 12A-12B illustrate an embodiment of a wound dressing incorporatingthe source of negative pressure and/or other electronic componentswithin the wound dressing;

FIG. 13A illustrates an embodiment of a wound dressing with the pumpand/or other electronics positioned away from the wound site;

FIG. 13B illustrates an embodiment of layers of a wound dressing withthe pump and electronic components offset from the absorbent area of thedressing;

FIG. 14 illustrates a side cross-sectional view of an embodiment of awound dressing with the pump and electronic components offset from theabsorbent area of the dressing positioned over the wound;

FIGS. 15-27 show embodiments of the wound dressing with the electroniccomponents offset from the absorbent material of the dressing;

FIG. 28A illustrates a side cross-sectional view of an embodiment of awound dressing system;

FIGS. 28B-28C illustrate a perspective view of an embodiment of a wounddressing system with a switch embedded into a wound dressing border;

FIGS. 29A and 29B illustrate two views of a switch integrated with awound dressing;

FIGS. 30A and 30B illustrate two views of a switch integrated with a tabthat extends away from a wound dressing border;

FIGS. 30C-3E show embodiments of wound dressings with a switchintegrated into the wound dressing border;

FIG. 31A is a top view of an embodiment of an exhaust system coupled toan outlet of a pump;

FIG. 31B is a perspective view of an embodiment of the exhaust systemcoupled to an outlet of a pump;

FIGS. 32A and 32B illustrate an embodiment of a wound dressing systemwith components of the wound dressing system;

FIG. 33A illustrates an embodiment of a connector and an extensionconduit for a wound dressing system;

FIG. 33B illustrates a perspective exploded view of an embodiment of theexhaust system of a wound dressing system;

FIG. 33C is a schematic side view of an embodiment of an end of anexhaust system between a top layer and a bottom layer of the wounddressing;

FIGS. 34A-34D illustrate embodiments of various views of duckbillnon-return valves;

FIGS. 35A-35C illustrate various views of embodiments of various reedvalves coupled to a pump outlet;

FIGS. 36A-36C illustrate various views of embodiments of a non-returnvalve having a crescent shape for integration into a wound dressing;

FIG. 37 illustrates an embodiment of a crescent shaped non-return valvepositioned superficially above an exhaust system and a wound dressing;

FIGS. 38A-38E illustrate various positions of an embodiment of anon-return valve in relation to a pump and an exhaust system; and

FIGS. 39A-39B illustrate two positions of an embodiment of acrescent-shaped non-return valve in relation to an exhaust system.

DETAILED DESCRIPTION

Embodiments disclosed herein relate to apparatuses and methods oftreating a wound with reduced pressure, including a source of negativepressure and wound dressing components and apparatuses. The apparatusesand components comprising the wound overlay and packing materials, ifany, are sometimes collectively referred to herein as dressings.

It will be appreciated that throughout this specification reference ismade to a wound. It is to be understood that the term wound is to bebroadly construed and encompasses open and closed wounds in which skinis torn, cut or punctured or where trauma causes a contusion, or anyother superficial or other conditions or imperfections on the skin of apatient or otherwise that benefit from reduced pressure treatment. Awound is thus broadly defined as any damaged region of tissue wherefluid may or may not be produced. Examples of such wounds include, butare not limited to, abdominal wounds or other large or incisionalwounds, either as a result of surgery, trauma, sterniotomies,fasciotomies, or other conditions, dehisced wounds, acute wounds,chronic wounds, subacute and dehisced wounds, traumatic wounds, flapsand skin grafts, lacerations, abrasions, contusions, bums, diabeticulcers, pressure ulcers, stoma, surgical wounds, trauma and venousulcers or the like.

It will be understood that embodiments of the present disclosure aregenerally applicable to use in topical negative pressure (“TNP”) therapysystems. Briefly, negative pressure wound therapy assists in the closureand healing of many forms of “hard to heal” wounds by reducing tissueoedema; encouraging blood flow and granular tissue formation; removingexcess exudate and may reduce bacterial load (and thus infection risk).In addition, the therapy allows for less disturbance of a wound leadingto more rapid healing. TNP therapy systems may also assist on thehealing of surgically closed wounds by removing fluid and by helping tostabilize the tissue in the apposed position of closure. A furtherbeneficial use of TNP therapy can be found in grafts and flaps whereremoval of excess fluid is important and close proximity of the graft totissue is required in order to ensure tissue viability.

As is used herein, reduced or negative pressure levels, such as −X mmHg,represent pressure levels relative to normal ambient atmosphericpressure, which can correspond to 760 mmHg (or 1 atm, 29.93 inHg,101.325 kPa, 14.696 psi, etc.). Accordingly, a negative pressure valueof −X mmHg reflects absolute pressure that is X mmHg below 760 mmHg or,in other words, an absolute pressure of (760−X) mmHg. In addition,negative pressure that is “less” or “smaller” than X mmHg corresponds topressure that is closer to atmospheric pressure (e.g., 31 40 mmHg isless than −60 mmHg). Negative pressure that is “more” or “greater” than−X mmHg corresponds to pressure that is further from atmosphericpressure (e.g., −80 mmHg is more than −60 mmHg). In some embodiments,local ambient atmospheric pressure is used as a reference point, andsuch local atmospheric pressure may not necessarily be, for example, 760mmHg.

The negative pressure range for some embodiments of the presentdisclosure can be approximately −80 mmHg, or between about −20 mmHg and31 200 mmHg. Note that these pressures are relative to normal ambientatmospheric pressure, which can be 760 mmHg. Thus, −200 mmHg would beabout 560 mmHg in practical terms. In some embodiments, the pressurerange can be between about −40 mmHg and −150 mmHg. Alternatively, apressure range of up to −75 mmHg, up to −80 mmHg or over −80 mmHg can beused. Also in other embodiments a pressure range of below −75 mmHg canbe used. Alternatively, a pressure range of over approximately −100mmHg, or even −150 mmHg, can be supplied by the negative pressureapparatus.

In some embodiments of wound closure devices described herein, increasedwound contraction can lead to increased tissue expansion in thesurrounding wound tissue. This effect may be increased by varying theforce applied to the tissue, for example by varying the negativepressure applied to the wound over time, possibly in conjunction withincreased tensile forces applied to the wound via embodiments of thewound closure devices. In some embodiments, negative pressure may bevaried over time for example using a sinusoidal wave, square wave,and/or in synchronization with one or more patient physiological indices(e.g., heartbeat). Examples of such applications where additionaldisclosure relating to the preceding may be found include U.S. Pat. No.8,235,955, titled “Wound treatment apparatus and method,” issued on Aug.7, 2012; and U.S. Pat. No. 7,753,894, titled “Wound cleansing apparatuswith stress,” issued Jul. 13, 2010. The disclosures of both of thesepatents are hereby incorporated by reference in their entirety.

International Application PCT/GB2012/000587, titled “WOUND DRESSING ANDMETHOD OF TREATMENT” and filed on Jul. 12, 2012, and published as WO2013/007973 A2 on Jan. 17, 2013, is an application, hereby incorporatedand considered to be part of this specification, that is directed toembodiments, methods of manufacture, and wound dressing components andwound treatment apparatuses that may be used in combination or inaddition to the embodiments described herein. Additionally, embodimentsof the wound dressings, wound treatment apparatuses and methodsdescribed herein may also be used in combination or in addition to thosedescribed in U.S. Provisional Application No. 61/650,904, filed May 23,2012, titled “APPARATUSES AND METHODS FOR NEGATIVE PRESSURE WOUNDTHERAPY,” International Application No. PCT/IB2013/001469, filed May 22,2013, titled “APPARATUSES AND METHODS FOR NEGATIVE PRESSURE WOUNDTHERAPY,” and published as WO 2013/175306 on Nov. 28, 2013, U.S. patentapplication Ser. No. 14/418,874, filed Jan. 30, 2015, published as U.S.Publication No. 2015/0216733, published Aug. 6, 2015, titled “WOUNDDRESSING AND METHOD OF TREATMENT,” U.S. patent application Ser. No.14/418,908, filed Jan. 30, 2015, published as U.S. Publication No.2015/0190286, published Jul. 9, 2015, titled “WOUND DRESSING AND METHODOF TREATMENT,” U.S. patent application Ser. No. 14/658,068, filed Mar.13, 2015, U.S. Application No. 2015/0182677, published Jul. 2, 2015,titled “WOUND DRESSING AND METHOD OF TREATMENT,” the disclosures ofwhich are hereby incorporated by reference in their entireties.Embodiments of the wound dressings, wound treatment apparatuses andmethods described herein may also be used in combination or in additionto those described in U.S. patent application Ser. No. 13/092,042, filedApr. 21 2011, published as US2011/0282309, titled “WOUND DRESSING ANDMETHOD OF USE,” and which is hereby incorporated by reference in itsentirety, including further details relating to embodiments of wounddressings, the wound dressing components and principles, and thematerials used for the wound dressings.

FIG. 1 illustrates an embodiment of a TNP wound treatment comprising awound dressing 100 in combination with a pump 108. As stated above, thewound dressing 100 can be any wound dressing embodiment disclosed hereinincluding without limitation dressing embodiment 100 or have anycombination of features of any number of wound dressing embodimentsdisclosed herein. Here, the dressing 100 may be placed over a wound, anda conduit 120 may then be connected to the port 150, although in someembodiments the dressing 100 may be provided with at least a portion ofthe conduit 120 preattached to the port 150. Preferably, the dressing100 is provided as a single article with all wound dressing elements(including the port 150) pre-attached and integrated into a single unit.The wound dressing 100 may then be connected, via the conduit 120, to asource of negative pressure such as the pump 108. The pump 108 can beminiaturized and portable, although larger conventional pumps may alsobe used with the dressing 100. In some embodiments, the pump 108 may beattached or mounted onto or adjacent the dressing 100. A connector 121may also be provided so as to permit the conduit 120 leading to thewound dressing 100 to be disconnected from the pump, which may be usefulfor example during dressing changes.

In some embodiments, a source of negative pressure (such as a pump) andsome or all other components of the TNP system, such as power source(s),sensor(s), connector(s), user interface component(s) (such as button(s),switch(es), speaker(s), screen(s), etc.) and the like, can be integralwith the wound dressing. As is illustrated in FIG. 2 , the source ofnegative pressure and battery can be included within the integrateddressing 200. Although FIG. 2 illustrates the source of negativepressure and battery 210 placed on top of the dressing layer 240 (suchas an absorbent layer), the source of negative pressure and one or morecomponents can be incorporated into the dressing differently. The sourceof negative pressure and the one or more components need not all beincorporated into the dressing in the same manner. For example, apressure sensor can be positioned below (or closer to the wound) thelayer 240 while the source of negative pressure can be positioned on topof the layer 240. FIGS. 6A-6D illustrate alternative arrangements forincorporating the negative pressure source and the one or morecomponents into the dressing. The integrated dressing 200 illustrated inFIG. 2 includes a cover layer 230 that includes for securing thedressing to skin surrounding the wound. The cover layer 230 can beformed of substantially fluid impermeable material, such as film. Thecover layer can include an adhesive for securing the dressing to thesurrounding skin or wound contact layer.

In some embodiments, the dressing can include the power source and othercomponents, such as electronics, on and/or incorporated into thedressing and can utilize a wound contact layer and a first spacer layerwithin the dressing. The wound contact layer can be configured to be incontact with the wound. The wound contact layer can include an adhesiveon the patient facing side for securing the dressing to the surroundingskin or on the top side for securing the wound contact layer to a coverlayer or other layer of the dressing. In operation, the wound contactlayer can be configured to provide unidirectional flow so as tofacilitate removal of exudate from the wound while blocking orsubstantially preventing exudate from returning to the wound. The firstspacer layer assists in distributing negative pressure over the woundsite and facilitating transport of wound exudate and fluids into thewound dressing. Further, an absorbent layer (such as layer 240) forabsorbing and retaining exudate aspirated from the wound can beutilized. In some embodiments, the absorbent includes a shaped form of asuperabsorber layer with recesses or compartments for the pump,electronics, and accompanying components. These layers can be coveredwith one layer of a film or cover layer (or a first cover layer). Thefirst cover layer can include a filter set that can be positioned withinone of the recesses. The filter can be configured to align with one ofthe at least one recesses of the absorbent layer, and the filter caninclude hydrophobic material to protect the pump and/or other componentsfrom liquid exudates. The filter can block fluids while permitting gasesto pass through. The pump, electronics, switch and battery can bepositioned on top of the first cover layer. Another section of spacer, asecond spacer, can be positioned above and/or surrounding the pump. Insome embodiments, the second spacer can be smaller than the first spacerused above the wound contact layer. A section of top film or cover layer(or a second cover layer) is positioned over the top of the secondspacer with a second filter associated with or positioned within thesecond cover layer. In some embodiments, the first and second coverlayer can be made of the same material. In some embodiments, the firstand second cover layers can be made of different material.

A second filter can be alternative or additionally used. For example,filter 220 can be constructed from antibacterial and/or antimicrobialmaterials so that the pump can exhaust gases into the atmosphere. Filter220 can also help to reduce noise produced by the pump.

In certain embodiments, the first and second cover layers include amoisture vapor permeable material that protects the pump and electroniccomponents from liquid exudate removed from the wound and other liquids,while allowing gases through. The pump and electronics can be pouchedbetween the fluid impermeable membranes or cover layers with the onlyinput and output being a filter on each side of the pump. The membranesand filter can protect the electronics from liquid from both sides. Insome embodiments, the dressing and integrated electronics pouch can beused in the shower and/or can be in contact with liquid without impedingthe operation of the pump and dressing.

In some embodiments, in addition to or instead of one or more batteries,one or more alternative energy generators (such as RF energy harvester,thermal energy harvester, and the like) can be included into the pump toprovide an alternative to traditional power sources. Examples of energyharvesters are described in U.S. Provisional Application No. 62/097,272,filed on Dec. 29, 2014 and U.S. Provisional Application No. 62/172,704,filed on Jun. 8, 2015, and titled “Negative Pressure Wound TherapyApparatus and Methods for Operating the Apparatus,” the disclosures ofwhich are incorporated by reference in their entireties.

FIG. 3 illustrates the layers of a wound dressing 300 with integratedpump and electronic components, such as a controller configured tocontrol the pump, according to some embodiments. The dressing layer 240includes a wound contact layer 310, a spacer layer 311, and an absorbentlayer 312. In some embodiments, the spacer layer 311 can be formed atleast partially from a three dimensional (3D) fabric. In certainembodiments, a superabsorbent material can be used in the absorbentlayer 312. The absorbent layer 312 can include one or more recesses 318(and 318 a) within the layer to accommodate placement of the pump,electronics, and/or power source. A moisture vapor permeable top film orfirst cover layer 313 is positioned above the absorbent layer 312. Thecover layer 313 can include a filter 320. The filter can be positionedin line with and above a recess 318 a in the absorbent layer 212.

A pump 316, electronics package 315, and power source 314 (such as abattery) can be positioned above the cover layer 313 as shown in FIG. 3. The pump 316, electronics package 315, and power source 314 can bepositioned on top of the cover layer 313 and at least partiallydepressed into the corresponding recesses 318 (and 318 a) in theabsorbent layer 312. For example, the pump 316 can be at least partiallydepressed in the recess 318 a. A packing layer 317 can be positionedabove and/or surrounding the pump 316, electronics package 315, andpower source 314. The packing layer 317 can be formed from spacermaterial and/or absorbent material. The packing layer 317 can include 3Dspacer. In some embodiments, the packing layer 317 additionally oralternatively can include a superabsorbent material. A second moisturevapor permeable top film or second cover layer 319 can be positionedover and seal the packing layer 317, pump 316, electronics package 315,and power source 314. The second cover layer 319 can also include asecond filter 220.

In some embodiments, the operation of the pump can vary depending on theenvironmental humidity level. It can be advantageous to providemechanisms to drive moisture out of the dressing or otherwise limit orcontrol the humidity of the dressing. In some embodiments, a chambergenerated by the layers above the pump can be used to act as apressurized sink for gases (such as gases exhausted by the pump),thereby increasing the relative humidity (or RH) and delta RH across theouter membrane, which in turn can increase the rate of evaporation.

FIG. 4 illustrates a cross-section of an integrated wound dressing 400showing the various layers according to some embodiments. The dressing400 includes three filters 420, 421, 422. First filter 422 can beprovided in the first wound contact layer below the pump and electroniccomponents similar to the first filter 320 in the first cover layer 313as described with reference to FIG. 3 . The dressing 400 can include asecond filter 421 positioned above a pump 416 as is shown in FIG. 4 . Inoperation, the pump 416 inflates chamber 430 with gases removed from thewound. After inflation, chamber 430 can provide both bolstering andcushioning of the dressing 400. As shown in FIG. 4 , an optionalsuperabsorber 432 can be included in the chamber 430 above a moisturevapor permeable film or cover layer 434 and below the moisture vaporpermeable top film or second cover layer 419. In such embodiments, thesuperabsorber 432 can draw fluid through the cover layer 434, and theincreased pressure in chamber 430 can facilitate an increasedevaporation to atmosphere. A third filter 420 can be positioned withinor adjacent to the second moisture vapor permeable top film or secondcover layer 419. Filter 420 can function similar to filter 220illustrated in FIG. 2

In some embodiments, the pump can include a piezoelectric transducerthat causes negative pressure to be supplied to the wound. In certainembodiments, a secondary device (such as a secondary piezoelectricdevice) can be used to generate atomisation of the fluid in thedressing, either accelerating evaporation of the water portion of thewound fluid or firing it through the moisture vapor permeable (MVP) topfilm where it can then evaporate. This can reduce or eliminate theeffect of environmental humidity on the capability of the dressing toevaporate water.

FIG. 5 illustrates a cross-section of an integrated wound dressing 500according to some embodiments. In the illustrated dressing 500, a toplayer or second cover layer 519 is optional. In some embodiments, one ormore ultrasonic oscillators 501 can be used to atomize water from thesuperabsorber and/or absorbent layer 512 or from between the top film orfirst cover layer 513 and the optional top film or second cover layer519. In some embodiments, oscillation can be provided by a separatecomponent such as a pump 516. In such embodiments, the one or moreultrasonic oscillators 501 would not be included in the dressing. Thedressing 500 includes a wound contact layer 510 and a spacer layer 511.

In some embodiments, the electronics and/or associated components can becontained in single or multiple sealed pockets or pouches. The pocketsor pouches can include the pump, electronics, and/or power source(s)(such as batteries) with or without a spacer layer padding. The packetsmay be designed to allow easy separation of the electronics from thedressing for disposal.

FIGS. 6A-6D illustrates embodiments of a pump pouch or pockets accordingto some embodiments. FIG. 6A illustrates an integrated wound dressing inwhich a pump 616 is placed on top of an absorbent layer. Electronics andpower source(s) can be similarly placed. FIG. 6B illustrates anintegrated wound dressing in which a pump 616 is positioned above thefirst cover layer 613 in a recess of the absorbent layer 612. Thispositioning is similar to that illustrated in FIG. 3 . Electronics andpower source(s) can be similarly placed.

FIGS. 6C-6D illustrate embodiments of wound dressings comprising a pumpand electronics package 650. The package 650 can also include powersource(s). The pump and electronics package 650 can be positioned in thedressing as described with reference to FIG. 3 . In other embodiments,the pump and electronics packages 650 can be positioned in alternativepositions than what is described with reference to FIG. 3 . For example,as depicted in FIG. 6C, the dressing can comprise a wound contact layer610, a spacer layer 611, a moisture vapor permeable film or first coverlayer 613 positioned above the contact layer 610 and spacer layer 611.The pump and electronics package 650 can be positioned above the firstcover layer 613. Additionally, the absorbent layer 622 can be positionedabove the first cover layer 613 and adjacent to the pump and electronicspackage 650. A second cover layer 619 can be positioned above theabsorbent layer 622 and can seal at the perimeter of the second coverlayer 619 to the wound contact layer 610 at the perimeter of the woundcontact layer 610. Filter 620 can be located adjacent to the pump andelectronics package 650. The filter 620 can be a hydrophobic filterconfigured to protect the pump and electronics package from exposure tofluid. Second filter 621 can be located on the second cover layer 619.The second filter can be located at a position adjacent to an outlet orexhaust of the pump system. Additionally or alternatively, the exhaustof the pump can be gaseously connected to the filter 621 positionedproximate to the exhaust. The gaseous connection can include one or moreconduits and/or chambers.

FIG. 6D illustrates an embodiment of a wound dressing with pump andelectronics package 650 positioned within the dressing. The dressing caninclude a wound contact layer 610 and spacer layer 611. A moisture vaporpermeable film or first cover layer 613 can be positioned above thewound contact layer 610 and the spacer layer 611. The pump andelectronics package 650 can be positioned above the first cover layer613. An absorbent layer 622 can be provided above the pump orelectronics package 650. A filter 620 can be provided between the pumpand electronics package 650 and the absorbent layer 622 as shown in FIG.6D. The filter 620 can protect the pump and electronics package 650 fromexposure to fluid. An additional filter or second filter 621 can beprovided on a second moisture vapor permeable film or second cover layer619. The filter 621 can be located at a position adjacent to an outletor exhaust of the pump system or proximate to the exhaust (and connectedto the exhaust via one or more conduits and/or chambers). For example,as is illustrated, a chamber 630 can gaseously connect the pump exhaustand the filter 621. In some embodiments, the chamber 630 can functionsimilar to the chamber 430 of FIG. 4 . Additionally or alternatively,the chamber 630 can be configured as a silencer to mute noise producedby the pump. The second cover layer 619 can be positioned above theabsorbent layer 622 and can seal at the perimeter of the second coverlayer 619 to the wound contact layer 610 at the perimeter of the woundcontact layer 610.

In some embodiments, a circumference port can be used to bring fluid tothe uppermost spacer layer first before being drawn down into thesuperabsorbent layer and pump. In some embodiments, a full circumferenceport or multiple circumferential ports can be used. The circumferenceports can be used at the perimeter of the wound dressing. This can makethe fluid behaviour independent of the direction the dressing is appliedin. Without this feature, the capacity can be lower if the port ispositioned at the bottom portion of the applied dressing.

In some embodiments, the whole pump pouch can be generated as a specificlayer that can be brought into the factory as a reel and/or folded rawmaterial, allowing the manufacture of a full system using the machineryused to manufacture the layers of a wound dressing. The pump and othercomponents can be placed into their respective compartments in thedressing.

In some embodiments, one or more of the following pump additions can beadded to the wound dressing with an integrated pump. The pressure sensorcan be added onto a substrate of the pump (for example, ceramicsubstrate). A pressure fuse can be utilized on the pump substrate todiscontinue operation of the pump if the pressure generated exceeds anacceptable threshold. Additionally, the pump can be designed forspecific pressures. The pump can be designed to disable provision ofnegative pressure if fluid enters the pump itself.

FIG. 7 illustrates a pressure fuse that can be used to discontinueoperation of the pump if the pressure exceeds an acceptable (or safe)threshold pressure according to some embodiments. As illustrated in FIG.7 , a void or bubble 701 (labeled as “3”) is provided within or adjacentto a piezo element 716 (labeled as “4”) of a pump. The void or bubble701 includes gas, such as gas stored at a pressure exceeding theoperating pressure of the pump. For example, if the pressure at region 2in FIG. 7 exceeds a pressure threshold (e.g., falls below −200 mmHg oranother suitable threshold value), then the void or bubble 701 burstsand thereby stops operation of the pump. For example, if the bubble 701ruptures, the piezo element will become inoperative and the pump will nolonger work. In other embodiments, the wiring to the piezo element orpump can run across the surface of the bubble (and/or inside thebubble). In such embodiment, bursting of the bubble could sever the wireand thereby stop or discontinue operation of the pump. The illustratedand described embodiments are not limited to pumps operated bypiezoelectric transducers. For example, a void or bubble can be used todeactivate or render inoperative voice coil pumps, diaphragm pumps, etc.

Further elements can be incorporated into the device to increase theusability of this device. For example, one or more of speaker(s) and/orvibration indicator(s) can be included. The pump can be operated via acontroller. One or more user interface elements for operating the pumpcan be included.

FIG. 8 illustrates an integrated wound dressing 800 with the pump andelectronics package incorporated within the dressing according to someembodiments. The dressing is similar to that described with reference toFIGS. 3-7 , except that the dressing 800 includes a different spacerlayer and absorbent layer arrangement. The spacer layer comprises achannel 801 that forms a ring about the wound dressing. The absorbentlayer 812 is surrounded by the spacer channel 801. There are additionalchannels 802 formed in the absorbent layer. The channels 801 and 802form chambers that can facilitate evaporation of fluid as is explainedabove in connection with FIG. 4 .

FIGS. 9A-9B illustrate integrated wound dressing 900 according to someembodiments. As illustrated in FIG. 9A, the integrated wound dressing900 comprises a tube 901 filled with magnetic fluid (or a solid magnet901). As illustrated in FIG. 9B, the tube 901 can be positioned on theperimeter of the spacer layer 911 and/or absorbent layer 912, and thetube 901 can run along or across the dressing 900. FIG. 9A alsoillustrates a coil of wire 902 excited by sinusoidal or other potentialdifference between points A and B. That is, the pump is actuated byelectromagnetic field (for example, the pump can be a voice coil pump).The dressing further comprises one or more pump chambers 903 positionedon the dressing as illustrated in FIG. 9A. Each of the pump chambers 903can include one or more one-way valves. In some embodiments, the pumpchambers can have an additional membrane or piston positioned betweenthe magnetic field and chamber.

As shown in FIG. 9B, the wound dressing can include a wound contactlayer 910 and a moisture vapor permeable top film or cover layer 913.The perimeter of the cover layer 913 can seal to the perimeter of thewound contact layer enclosing the components of the wound dressingapparatus.

FIGS. 10-12 show embodiments of integrated dressings. FIG. 10illustrates a close up view of one end of the wound dressing. The pump1016 is visible as a dark spot under the top layer.

FIG. 11A shows a top view of a wound dressing where the pump andassociated components are visible. The pump 1116, electronics package1115, switch 1160 for operating the pump (e.g., turning the pumpon/off), and power source 1114 are visible from the top of the dressing.

FIG. 11B shows a bottom view of a wound dressing where recesses for thepump and associated components are visible. Recess 1216 can be a pumprecess, recess 1215 can be an electronics package recess, and recess1214 can be a power source recess.

In some embodiments, the pump and/or other electronic components can beconfigured to be positioned adjacent to or next to the absorbent and/ortransmission layers so that the pump and/or other electronic componentsare still part of a single apparatus to be applied to a patient, but thepump and/or other electronics are positioned away from the wound site.

In some embodiments, the pump and/or other electronic components can beconfigured to be positioned adjacent to or next to the absorbent and/ortransmission layers so that the pump and/or other electronic componentsare still part of a single apparatus to be applied to a patient with thepump and/or other electronics positioned away from the wound site. FIGS.12A-12B illustrates a wound dressing incorporating the source ofnegative pressure and/or other electronic components within the wounddressing. FIGS. 12A-12B illustrates a wound dressing 1200 with the pumpand/or other electronics positioned away from the wound site. The wounddressing can include an electronics area 1261 and an absorbent area1260. The dressing can comprise a wound contact layer (not shown) and amoisture vapor permeable film or cover layer 1213 positioned above thecontact layer and other layers of the dressing. The wound dressinglayers and components of the electronics area as well as the absorbentarea can be covered by one continuous cover layer 1213 as shown in FIGS.12A-12B.

The electronics area 1261 can include a source of negative pressure(such as a pump) and some or all other components of the TNP system,such as power source(s), sensor(s), connector(s), user interfacecomponent(s) (such as button(s), switch(es), speaker(s), screen(s),etc.) and the like, that can be integral with the wound dressing. Forexample, the electronics area 1261 can include a button or switch 1211as shown in FIG. 12A-12B. The button or switch 1211 can be used foroperating the pump (e.g., turning the pump on/off).

The absorbent area 1260 can include an absorbent material 1212 and canbe positioned over the wound site. The electronics area 1261 can bepositioned away from the wound site, such as by being located off to theside from the absorbent area 1260. The electronics area 1261 can bepositioned adjacent to and in fluid communication with the absorbentarea 1260 as shown in FIGS. 12A-12B. In some embodiments, each of theelectronics area 1261 and absorbent area 1260 may be rectangular inshape and positioned adjacent to one another.

In some embodiments, additional layers of dressing material can beincluded in the electronics area 1261, the absorbent area 1260, or bothareas. In some embodiments, the dressing can comprise one or more spacerlayers and/or one or more absorbent layer positioned above the contactlayer and below the wound cover layer 1213 of the dressing.

The dressing can comprise a wound contact layer (not shown), a spacerlayer (not shown), an absorbent layer 1212, a moisture vapor permeablefilm or cover layer 1213 positioned above the wound contact layer,spacer layer, absorbent layer, or other layers of the dressing. Thewound contact layer can be configured to be in contact with the wound.The wound contact layer can include an adhesive on the patient facingside for securing the dressing to the surrounding skin or on the topside for securing the wound contact layer to a cover layer or otherlayer of the dressing. In operation, the wound contact layer can beconfigured to provide unidirectional flow so as to facilitate removal ofexudate from the wound while blocking or substantially preventingexudate from returning to the wound. The first spacer layer assists indistributing negative pressure over the wound site and facilitatingtransport of wound exudate and fluids into the wound dressing. In someembodiments, the spacer layer can be formed at least partially from athree dimensional (3D) fabric. Further, an absorbent layer (such aslayer 1212) for absorbing and retaining exudate aspirated from the woundcan be utilized. In some embodiments, a superabsorbent material can beused in the absorbent layer 1212. In some embodiments, the absorbentincludes a shaped form of a superabsorber layer. The wound dressinglayers of the electronics area and the absorbent layer can be covered byone continuous cover layer 1213. In some embodiments, the cover layercan include a moisture vapor permeable material that prevents liquidexudate removed from the wound and other liquids from passing through,while allowing gases through.

FIG. 13A illustrates a wound dressing with the pump and/or otherelectronics positioned away from the wound site. The wound dressing caninclude an electronics area 1361 and an absorbent area 1360. Theabsorbent area 1360 can include an absorbent material 1312 and can bepositioned over the wound site. The electronics area 1361 can bepositioned away from the wound site, such as by being located off to theside from the absorbent area 1360. The electronics area 1361 can bepositioned adjacent to and in fluid communication with the absorbentarea 1360. In some embodiments, each of the electronics area 1361 andabsorbent area 1360 may be rectangular in shape, and positioned adjacentto one another to form a T-shape. In such an embodiment, each of theareas 1360 and 1361 are elongated with longitudinal axes that areperpendicular or substantially perpendicular to one another. As shown inFIG. 13A, the top portion of the T can be where the electronics would belocated, and the bottom of the T can be placed on the wound.

FIG. 13B illustrates an embodiment of layers of a wound dressing withthe pump and electronic components offset from the absorbent area of thedressing. As illustrated in FIG. 13B, the dressing can include a woundcontact layer 1310 for placing in contact with the wound. Lower spacerlayers 1311 and 1311′ are provided above the wound contact layer 1310.In some embodiments, the spacer layer 1311 can be a separate layer fromspacer layer 1311′ as shown in FIG. 13B. The lower spacer layers 1311and/or 1311′ can assist in distributing pressure evenly to the woundsurface and/or wicking fluid away from the wound. An absorbent layer1322 can be positioned above the lower spacer layer 1311. A dressinglayer 1351 can include cutouts or recesses 1328 for embedding theelectronic components 1350 within the layer 1351. In some embodiments,the cutouts or recesses 1328 can be sized and shaped to embed a pump1327, power source 1326, and/or other electronic components. In someembodiments, the layer 1351 can include multiple spacer layers stackedtogether. In some embodiments, the layer 1351 can include multiplespacer layers pieced together to surround the electronic components1350. An upper spacer layer can be provided above the absorbent layer1322, layer 1351, and/or electronic components 1350. A cover layer orbacking layer 1313 can be positioned over the upper spacer layer. Thebacking layer 1313 can form a seal to the wound contact layer 1310 at aperimeter region enclosing the spacer layers 1311, 1311′, and 1317, theabsorbent layer 1322, layer 1351, and electronic components 1350. Insome embodiments, the backing layer 1313 can be a flexible sheet ofmaterial that forms and molds around the dressing components when theyare applied to the wound. In other embodiments, the backing layer 1313can be a material that is preformed or premolded to fit around thedressing components as shown in FIG. 13B.

FIG. 14 illustrates an embodiment of a wound dressing with the pump andelectronic components offset from the absorbent area of the dressingpositioned over the wound. The wound dressing can comprise a woundcontact layer 1310 and a moisture vapor permeable film or cover layer1313 that enclose an absorbent area 1360 and an electronics area 1361.The cover layer 1313 can seal at the perimeter of the cover layer 1319to the wound contact layer 1310 at the perimeter of the wound contactlayer. The dressing can comprise an upper spacer layer or first spacerlayer 1317 that includes a continuous layer of spacer materialpositioned below the cover layer 1313 and above the layers of theabsorbent area and the layers of the electronics area. The continuouslayer of spacer material or upper spacer layer 1317 can enable an airpathway between the two areas of the dressing as illustrated by blackdirectional arrows in FIG. 14 .

The absorbent area 1360 of the dressing can comprise a second spacerlayer 1311 or lower spacer layer and an absorbent layer 1322 positionedabove the wound contact layer 1310. The second spacer layer 1311 canallow for an open air path over the wound site. The absorbent layer 1322can comprise a super absorber positioned in the absorbent area 1360 ofthe dressing. The absorbent layer 1322 can retain wound fluid withinthereby preventing fluid passage of wound exudates into the electronicsarea 1361 of the dressing. The wound fluids can flow through the woundcontact layer 1310, to the lower spacer layer 1311, and into theabsorbent layer 1322. The wound fluids are then spread throughout theabsorbent layer 1322 and retained in the absorbent layer 1322 as shownby the white directional arrows for wound fluids in FIG. 14 .

The electronics area 1361 of the dressing can comprise a plurality oflayers of spacer material 1351. In some embodiments, the electroniccomponents 1350 embedded within the plurality of layers of spacermaterial 1351. The layers of spacer material can have recesses or cutouts to embed the electronic components within whilst providingstructure to prevent collapse. The electronic components 1350 caninclude a pump, power source, controller, and/or an electronics package,although any suitable electronics component is appreciated. In someembodiments, a barrier and/or partition can be provided between theabsorbent area 1360 and the dressing layers surrounding the electroniccomponents in the electronics area 1361. A partition 1362 can optionallybe positioned between the absorbent area 1360 and the electronics area1361. The partition 1362 can separate the absorbent layer 1322 and lowerair flow spacer layer 1311 from the electronic housing segment of thedressing in the electronic area. The partition 1362 can prevent woundfluid (e.g., wound exudate) from entering the electronic housing sectionof the dressing. In some embodiments, the partition can be a non-porousdam or other structure. The non-porous dam 1362 can comprise acyanoacrylate adhesive bead or a strip of silicone. The air pathwaythrough the dressing is shown in FIG. 14 by directional arrows. The airflows through the wound contact layer 1310, the lower spacer layer 1311,and the absorbent layer 1322 and into the first spacer layer 1317. Theair can travel horizontally through the first spacer layer 1317 over andaround the partition 1362 into the electronics area of the dressing asillustrated by the black directional arrows in FIG. 14 .

A pump exhaust 1370 can be provided to exhaust air from the pump to theoutside of the dressing. The pump exhaust can be in communication withthe electronics area 1361 and the outside of the dressing. In someembodiments, the pump exhaust 1370 can be a flexible fluidic connectorthat comprises a 3D material that allows for pressure to be appliedwithout collapse of the exhaust port as described in more detail herein.Examples of an application where additional disclosure relating to the3D material can be found include US Publication No. 2015/0141941, titled“Apparatuses and Methods for Negative Pressure Wound Therapy” publishedon May 21, 2015. The disclosure of this patent is hereby incorporated byreference in its entirety.

FIGS. 15-27 show embodiments of the wound dressing with the electroniccomponents 1350 offset from the absorbent material 1322 of the dressing.FIGS. 15-27 show the wound dressing similar to the dressing describedwith reference to FIG. 14 . In FIG. 15 the dressing is shown with theportion of the upper or first spacer layer 1317 over the electronic area1361 folded back and exposing an underlying spacer layer of theplurality of spacer layers 1351 in the electronics area 1361.

FIGS. 16 and 17 show a top view of the wound dressing with theelectronic components 1350 offset from the absorbent layer 1322 with thecontinuous upper or first spacer layer 1317 shown over the absorbentarea 1360 and the electronics area 1361.

FIG. 18 shows the dressing with a portion of the top or first spacerlayer 1317 over the electronic area folded back and exposing underlyingspacer layer 1351 in the electronics area and the electronic components1350. FIG. 19 shows one of the plurality of spacer layers 1351 beingremoved and exposing the underlying electronic components 1350. FIG. 20shows one of the plurality of spacer layers 1351 with recesses in spacerlayer with an electronic component embedded within the recess.

FIGS. 21-23 shows the wound dressing with the electronic components 1350exposed and the recessed spacer layers removed. At least one of theplurality of transmission layers 1351 are provided below the electroniccomponents 1350 for cushioning as shown in FIGS. 21-23 . FIG. 24 showsan embodiment of a wound dressing with a spacer layer 1351 with recessesprovided around the electronic components 1350. FIGS. 25-26 show thewound dressing with pieces of spacer material 1351 a placed around theelectronic components 1350. FIG. 27 shows the wound dressing with thepieces of spacer material 1351 a and an additional layer of spacermaterial 1351 provided over it. In some embodiments, the dressingmaterial in the electronics area can be a material that has the samecompressibility as the absorbent material. This can allow for theelectronics area to have a uniform surface with the absorbent area whencompressed.

The dressings described in FIGS. 13-27 incorporate electronic componentsin a portion of the dressing offset from the portion of the dressingplaced over the wound. Components can be incorporated into the dressingto provide a barrier that stops liquid from entering into the area nearthe electronics. One of those methods described with reference to FIG.14 includes the use of a partition or non-porous dam positioned betweena portion of the electronics area and the absorbent area. In someembodiments, the dressing can be composed of two separate pouches and aport that connects the two pouches with a filter over the negativepressure port. For example, the dressing can include an electronicspouch and a dressing pouch and the wound dressing can utilize a fluidicconnector positioned between the two pouches. The two pouches can beconnected or enclosed by a wound contact layer and wound cover layersealed around the two pouches thereby incorporating the pouches into onedressing unit. In some embodiments, the fluidic connector incommunication with the two pouches can be a flexible fluidic connectorthat comprises a 3D material that allows for pressure to be appliedwithout collapse of the connector. Examples of an application whereadditional disclosure relating to the fluidic connector can be foundinclude US Publication No. 2015/0141941, titled “Apparatuses and Methodsfor Negative Pressure Wound Therapy” published on May 21, 2015. Thedisclosure of this patent is hereby incorporated by reference in itsentirety.

In some embodiments, the absorbent components and electronics componentscan be overlapping but offset. For example, a portion of the electronicsarea can overlap the absorbent area, for example overlapping thesuperabsorber layer, but the electronics area is not completely over theabsorbent area. Therefore, a portion of the electronics area can beoffset from the absorbent area and only provided over the cushioningspacer layers.

FIG. 28A is a side cross-sectional view of a wound dressing system 1300,according to some embodiments. FIG. 28A illustrates a cross-sectionalview of the wound dressing system with components of the wound dressingsystem similar to the wound dressing system as illustrated in FIG. 14 .Unless otherwise noted, reference numerals and like-named components inFIG. 28A refer to components that are the same as or generally similarto the components of FIG. 14 . As shown in FIG. 28A, the wound dressingsystem 1300 can include a wound dressing 1302 with one or more embedded(also referred to as integrated) electronic components 1350. The wounddressing 1302 can include a wound dressing body 1332 and a wounddressing border 1334. The wound dressing border 1334 can extend aroundat least a portion of the perimeter of the wound dressing body 1332. Forexample, in some embodiments, the wound dressing border 1334 can extendaround the entire perimeter of the wound dressing body 1332. The wounddressing border 1334 can extend away from the wound dressing body 1332any suitable distance (also referred to as the border length), such as,for example, a distance in the range of about 0.5 cm to about 3.0 cm,although any suitable distance is contemplated, including distancesshorter than 0.5 cm or longer than 3.0 cm. Different portions of thewound dressing border 1334 can have different border lengths. Forexample, for wound dressings 1302 that have generally rectangularshapes, the border lengths of the four corners can be longer relative tothe border lengths of the four straight portions of the wound dressingborder 1334. The wound dressing 1302 can include an absorbent area 1360and an electronics area 1361. In some embodiments, the electroniccomponents 1350 can be positioned within the wound dressing 1302 in theelectronics area 1361, although it should be appreciated that theelectronic components 1350 can be integrated with the wound dressing1302 in any suitable arrangement (e.g., disposed on and/or positionedwithin the wound dressing 1302, among others). The electronic components1350 can optionally include a pump 1304, a power source, a controller,and/or an electronics package, although any suitable electroniccomponent is appreciated. The pump 1304 can be in fluidic communicationwith one or more regions of the wound dressing 1302, such as, forexample, the absorbent area 1360 of the dressing. The absorbent area1360 and the electronics area 1361 of the wound dressing 1302 can haveany suitable arrangement. For example, FIG. 28A illustrates anembodiment of the wound dressing 1302 in which the electronics area 1361is offset from the absorbent area 1360.

As shown in FIG. 28A, the wound dressing system 1300 can include aswitch 1330 to control the operation of the wound dressing system 1300.The switch 1330 can be integrated with the wound dressing 1302. Forexample, in some embodiments, the switch 1330 can be integrated with thewound dressing body 1332 or the wound dressing border 1334. The switchcan be positioned within, disposed on, and/or embedded in the wounddressing body 1332 or the wound dressing border 1334, although it shouldbe appreciated that the switch 1330 can be integrated with any suitablepart of the wound dressing 1302. For example, as described in moredetail below, in some embodiments, the switch 1330 can be positionedover a flexiboard layer and/or positioned on a tab. The flexiboard layerand/or tab can allow for the switch 1330 to be actuated (e.g. activated,deactivated, and/or selected) without causing trauma or discomfort tousers' wound sites. Accordingly, even when users actuate the switch 1330with compressive and/or shear forces (e.g., from pushing down on theswitch or pressing on the switch in a plurality of directions), theflexiboard layer and/or tab advantageously inhibits or reduces theamount of force transferred to users' wound sites. For example, theflexiboard layer can absorb and/or dissipate forces before they reachthe wound site.

The switch can be electrically connected to one or more of theelectrical components 1350 of the wound dressing system 1300. Forexample, in some embodiments, the switch 1330 can be electricallyconnected to the pump 1304, a power source, a controller, and/or anelectronics package, although any suitable electronic component isappreciated. In some embodiments, the switch can be wired and/or be inwireless communication with one or more of the electrical components1350. The switch 1330 can be selectively operable to control one or moreof the electrical components 1350. For example, in some embodiments, theswitch can be actuated by users to turn on and turn off the pump 1304and/or a power source. In some embodiments, the switch 1330 can beselectively operable by users to control one or more operatingconditions of the pump 1304 (e.g., to toggle through a plurality ofoperating states or levels of the pump 1304) in addition to or insteadof powering on and powering off the wound dressing system 1300. Forexample, the switch 1330 can be electrically connected to a controllerof the wound dressing system 1300 such that users can control variousfeatures of the pump 1304, including, for example, the negative pressurelevel delivered by the pump 1304 (e.g., pressure levels in the range ofabout −40 mmHg to −150 mmHg, among others), the type of pressure wavedelivered by the pump 1304 (e.g., sinusoidal, sawtooth, and the like),and/or the operating mode of the pump 1304 (e.g., continuous orintermittent). For example, in some embodiments, one press of the switch1330 can turn on the pump 1304 and cause the pump 1304 to deliver atarget pressure of −40 mmHg, two presses of the switch 1330 after thepump 1304 has been turned on can cause the pump 1304 to deliver a targetpressure of −80 mmHg, and holding the switch 1330 down for apredetermined amount of time (e.g., 2 seconds) can cause the pump 1304to turn off. Other actuation combinations for controlling the wounddressing system 1300 with the switch 1330 are also appreciated. In someembodiments, a plurality of switches can be integrated with the wounddressing 1302 to control the wound dressing system 1300.

FIG. 28B is a perspective view of a wound dressing system 1300 with aswitch 1330 embedded into a wound dressing border 1334, according tosome embodiments. FIG. 28C also includes a magnified partial perspectiveview of the corner of the wound dressing system 1300 that includes theswitch 1330. Unless otherwise noted, reference numerals and like-namedcomponents in FIG. 28B and 28C refer to components that are the same asor generally similar to the components of FIG. 28A. As shown in FIG.28B, the wound dressing system 1300 can include an exhaust system 1370to exhaust air from a pump embedded in the wound dressing 1302 to theoutside of the wound dressing 1302 (e.g., to the environment). Theexhaust system 1370 can be similar to the exhaust system described inmore detail below.

As shown in FIG. 28B and 28C, the switch 1330 can optionally bepositioned on a corner of the wound dressing border 1334. However, itshould be appreciated that the switch 1330 can be integrated with thewound dressing border 1334 or the wound dressing body 1332 at anysuitable location. In some embodiments, the switch 1330 can optionallybe positioned in a sub-flush position relative to the cover layer 1313to inhibit or prevent accidental and/or inadvertent actuation of theswitch 1330 (e.g., from a user laying on the wound dressing 1302). Forexample, a bottom surface of the switch 1330 can be positioned below atop surface of the cover layer 1313 (e.g., so that the height of theswitch 1330 does not extend past a plane defined by the wound dressingborder 1334).

The partially magnified perspective view of the corner in FIG. 28C showsthat the wound dressing system 1300 can include one or more indicators1331. The one or more indicators 1331 can extend (e.g.,circumferentially extend) around at least a portion of the perimeter ofthe switch 1330. The one or more indicators 1331 can indicate one ormore statuses of the wound dressing system 1330, such as, for example,battery level (e.g., above 30% remaining and 30% or less remaining),pressure level (e.g., a first pressure level and a second pressurelevel), operating problems (e.g., a leak and/or a blockage condition),among any other suitable statuses. In some embodiments, the one or moreindicators 1331 can include one or more visual indicators, audioindicators, tactile indicators, and the like. For example, in someembodiments, the one or more indicators 1331 can include one or morelight emitting diodes (LEDs). The one or more indicators can include anarray of LEDs. In some embodiments, one or more LEDs can, for example,flash or illuminate in a particular color to indicate a particularoperating status. For example, the one or more LEDs can flash toindicate the presence of an operating problem (e.g., a leak and/or ablockage condition), illuminate in a solid color to indicate a batterylevel (e.g., illuminate solid green for a battery level above athreshold percentage (e.g., 30%) and illuminate solid orange for abattery level at or below the threshold percentage). In someembodiments, the switch 1330 can be used to power on and power off oneor more electrical components of the wound dressing system 1300, suchas, for example, a pump, a power source, a controller, and/or anelectronics package, among others. For example, the switch 1330 can beelectrically connected to one or more such electrical components via awire conduit 1340 shown in the partially magnified perspective view inFIG. 28C. The wire conduit 1340 can pass between layers of the dressing.For example, in some embodiments, the wire conduit 1340 can bepositioned between the cover layer 1313 and a bottom wound contact layer(not shown).

FIGS. 29A and 29B are two views of the switch 1330 of FIGS. 28B and 28Cintegrated with a wound dressing 1302, according to some embodiments.FIG. 29A is a perspective view of the switch 1330 positioned above aflexiboard layer 1336 and FIG. 29B is a side cross-sectional view of theswitch 1330 positioned above the flexiboard layer 1336. Unless otherwisenoted, reference numerals and like-named components in FIGS. 29A and 29Brefer to components that are the same as or generally similar to thecomponents of FIGS. 28A-28C. As shown in FIG. 29A, the cover layer 1313of the wound dressing 1302 can include a plurality of holes 1335 (alsoreferred to as breathing pores) to allow air to circulate through thewound dressing border 1334. The flexiboard layer 1336 can be positionedbelow the cover layer 1313 and the switch 1330 so that when the switch1330 is actuated (e.g., the switch is pressed, or a force is applied toit) the flexiboard layer 1336 inhibits or reduces the amount of forcetransferred to the wound site and surrounding tissue. The flexiboardlayer 1336 can be any suitable rigid, semi-rigid, and/or semi-flexiblematerial capable of dissipating compression forces on the wound dressing1302. The extent of the flexiboard layer 1336 in FIG. 29A is shown bythe plurality of holes 1335 in the cover layer 1313 that are shaded. Thewound contact layer 1310 is shown in FIG. 29A by the plurality of holes1335 in the cover layer 1313 that are not shaded. In some embodiments,the flexiboard layer 1336 can extend outward from the center of theswitch 1330 in the range of about 0.5 cm to 3.0 cm, although anysuitable distance is appreciated, including distances shorter than 0.5cm and distances greater than 3.0 cm. In some embodiments, the one ormore indicators 1331 can include a first indicator 1331 a and a secondindicator 1331 b, although any suitable number is appreciated.

FIG. 29B is similar to FIG. 29A except that FIG. 29B is a sidecross-sectional view of the switch 1330 of FIG. 28B and 28C embedded inthe wound dressing border 1334. As shown in FIG. 29B, the switch 1330can be positioned above a flexiboard layer 1336. The flexiboard layer1336 can extend a distance away from a center of the switch 1330. Insome embodiments, the flexiboard layer 1336 can extend the width of thewound dressing border 1334 (e.g., the width defined between the wounddressing body 1332 and the outer edge of the wound dressing border1334). In some embodiments, the one or more indicators 1331 can bepositioned adjacent the switch 1330 (e.g., can extend around or canextend circumferentially around the switch 1330). A cover layer 1313 canbe positioned around the one or more indicators 1331 and the switch 1330and on top of the flexiboard layer 1336. The flexiboard layer 1336 canbe positioned above the wound contact layer 1310. As shown in FIG. 29B,the switch 1330 can be positioned in a sub-flush position relative tothe one or more indicators 1331 to reduce the likelihood ofaccidental/inadvertent actuation of the switch 1330. A forefinger isshown depressing the switch 1330. In some embodiments, the switch 1330can be actuated by pressing the switch 1330 in a first direction with aforefinger (e.g., a downward direction).

FIGS. 30A and 30B are two views of a switch 1330 integrated with a tab1338 that extends away from a wound dressing border 1334, according tosome embodiments. FIG. 30A is a perspective view of the switch 1330positioned on the tab 1338 and FIG. 30B is a side cross-sectional viewof the switch 1330 positioned on the tab 1338, with the tab 1338 liftedat an angle relative to a plane of the wound dressing 1302. Unlessotherwise noted, reference numerals and like-named components in FIGS.30A and 30B refer to components that are the same as or generallysimilar to the components of FIGS. 28A-29B. As shown in FIG. 30A, thetab 1338 can be attached to a peripheral edge of the wound dressingborder 1334, although any other suitable location is appreciated, suchas, for example, the middle of the wound dressing border 1334 or an edgeof the wound dressing body 1332, among others. The wound dressing 1302can optionally include a joint 1339 (also referred to as a seam, acrease, and/or a border) where the tab 1338 and the wound dressingborder 1334 attach (or otherwise come together). The joint 1339 canadvantageously allow the tab to pivot (also referred to as rotate) aboutthe joint 1339 (e.g., like a hinge) so that users can optionally movethe tab 1338 before actuating the switch 1330. In some embodiments, thetab 1338 can have a rest position in which it abuts up against the wounddressing border 1334 (e.g., extends along the same plane as the wounddressing border 1334), the wound dressing body, and/or the patientbefore a user moves the tab 1338. In some embodiments, the tab 1338 canbe lifted about the joint 1339 (e.g., so that it extends at an anglerelative to the wound dressing border 1334 and is not in contact withthe patient's skin) so that no force is transferred to the patient'sbody when the switch 1330 is actuated. For example, in some embodiments,the switch 1330 can be actuated by applying a force to the switch 1330in two opposing directions, such as, for example, on first and secondsides of the tab 1338 a, 1338 b (e.g., by pressing the switch with twofingers, as shown in FIG. 30B). The tab 1338 can therefore allow usersto lift up the tab 1338, which advantageously inhibits (e.g., prevents)trauma to the wound and surrounding tissue by actuating the switch 1330,as shown by the two fingers in FIG. 30B (e.g., between a thumb and aforefinger). FIG. 30B shows that the switch 1330 and the one or moreindicators 1331 can be attached to the underside of the cover layer1313. In some embodiments, a flexiboard 1336 can optionally be attachedto the tab 1338, such as, for example, below the switch 1330. In someembodiments, the electrical connection between the switch 1330 and thepump in the wound dressing can be positioned between the cover layer1313 and the wound contact layer 1310, although any suitable arrangementis appreciated. As shown in FIG. 30B, the switch 1330 can be positionedin a sub-flush position relative to the one or more indicators 1331 toreduce the likelihood of accidental/inadvertent actuation of the switch1330.

FIGS. 30C-3E show embodiments of wound dressings with a switch 1330integrated into the wound dressing border 1334. In some embodiments, theswitch 1330 can be electrically connected to one or more such electricalcomponents via a wire conduit 1340 shown in FIGS. 30C-3D. The wireconduit 1340 can pass between layers of the dressing. For example, insome embodiments, the wire conduit 1340 can be positioned between abacking or cover layer and a bottom wound contact layer. FIG. 30Aillustrates a wound dressing with integrated switch at the wounddressing boarder before negative pressure is applied. FIG. 30Dillustrates a wound dressing with integrated switch at the wounddressing boarder after negative pressure is applied. As shown in FIG.30D, when negative pressure is applied, the wound dressing componentsare pulled downward and an imprint of the electronic components 1350 isvisible in the electronics area of the dressing. FIG. 30E shows thewound dressing components with the backing layer and wound contact layerremoved. The switch 1330 is shown adjacent to the dressing layers of theelectronics area 1360 and the wire conduit and/or electrical connections1340 are shown extending from the switch to the electronics area 1360 ofthe dressing.

As described previously, FIG. 11 illustrates a top view of a wounddressing system with a switch 1160 embedded within a wound dressingbody, according to some embodiments. The pump 1116, electroniccomponents 1115, and switch 1160 for operating the pump (e.g., turningthe pump on/off), and power source 1114 are visible from the top of thewound dressing. As shown in FIG. 11A, a dressing layer can be positionedover the switch 1160 to keep it sterile.

As shown in FIG. 28A, the negative pressure wound therapy system 1300can include an exhaust system 1370 (also referred to as a dressingexhaust or a pump exhaust) to exhaust air from the pump 1304 to theoutside of the wound dressing 1302 (e.g., to the environment). In someembodiments, the exhaust system 1370 can be in communication with theelectronics area 1361 and the environment outside of the dressing 1302.As described in more detail below, in some embodiments, the exhaustsystem 1370 can be a flexible fluidic connector (also referred to as aflexible port) that includes a 3D material that allows for pressure(e.g., a compression force applied via compression of the wound dressing1302) to be applied to the exhaust system 1370 without causing thecollapse of its exhaust port. Accordingly, even when the wound dressing1302 and exhaust system 1370 is subjected to a compression force (e.g.,from the patient laying on the wound dressing 1302), the exhaust system1370 advantageously exhausts air from the wound site while inhibitingthe collapse and occlusion of the exhaust pathway. Examples of anapplication where additional disclosure relating to the 3D material canbe found include US Publication No. 2015/0141941, titled “Apparatusesand Methods for Negative Pressure Wound Therapy” published on May 21,2015. The disclosure of this patent is hereby incorporated by referencein its entirety.

FIG. 31A is a top view of the exhaust system 1370 of FIG. 28A showncoupled to an outlet of a pump 1304, according to some embodiments. Thewound dressing 1302 has been removed for purposes of illustration. Thepump 1304 includes an inlet 1304 a and an outlet 1304 b. As shown inFIG. 31A, the exhaust system 1370 can include a connector 1376 includinga spacer 1372 enveloped (also referred to as embedded) in a film 1374.In some embodiments, the film 1374 can define a chamber and the spacer1372 can be positioned within the chamber. The connector 1376 can definea flow path through which gas (e.g., air) exhausted from the pump 1304can flow through. The flow path can include a portion of the chamber. Insome embodiments, the flow path can include the entire chamber.Advantageously, the spacer 1372 can resist collapse of the connector1376 when the connector 1376 is compressed, thereby inhibiting the flowpath of the connector 1376 from becoming occluded. The spacer 1372 canbe any suitable 3D material capable of resisting compression in at leastone direction, thereby enabling effective transmission of exhaust airtherethrough. In some embodiments, the spacer 1372 can be flexible andcapable of returning to its original shape after being deformed. In someembodiments, the 3D material can be constructed from antibacterialand/or antimicrobial filter materials so that the pump 1304 can exhaustfiltered gases into the atmosphere. In some embodiments, the spacer 1372can be freely movable within the film 1374. In some embodiments, thespacer 1372 can be freely movable within a chamber defined between topand bottom layers of the film 1374. Any suitably sized spacer 1372 isappreciated.

The film 1374 can be a clear plastic film, although any suitablematerial is appreciated, such as, for example, a Versapore film having apore size diameter of about 2 μm. The film 1374 can be flexible. One ormore edges of the film 1374 can provide a gas tight seal. The gas tightseal(s) can prevent air from the environment from leaking into theconnector 1376. In some embodiments, the film 1374 can include top andbottom layers of a clear plastic film (or other suitable material, e.g.,Versapore). One or more edges of the top and bottom layers can bethermally bonded to each other to provide a gas tight seal that canprevent air from the environment from leaking into the connector 1376.It should be appreciated that the gas tight seal along one or more edges(also referred to as one or more portions along a perimeter) of theconnector 1376 can be sealed with any suitable process for any suitablefilm 1374 material. In some embodiments, the spacer 1372 can be freelymovable within a chamber defined between the top and bottom layers ofthe film 1374.

As described above, the connector 1376 can define a flow path throughwhich exhaust gas can flow. For example, in some embodiments, the flowpath through the connector 1376 can extend between a first opening 1374a and a second opening 1374 b of the film 1374. The portion of the flowpath extending between the first and second openings 1374 a, 1374 b caninclude one or more channels defined within the connector 1376. In someembodiments, the one or more channels can define a generally tubularflow path that flows around the outside of the spacer 1372 but on theinside of the film 1374. For example, in some embodiments, the one ormore channels can be defined by the open space between one or moresurfaces (also referred to as sides) of the spacer 1372 and one or moreinterior surfaces of the film 1374. In some embodiments, the flow pathcan optionally include at least a portion of the spacer 1372. Forexample, in some embodiments, the flow path between the first and secondopenings 1374 a, 1374 b can extend through a portion of the spacer 1372(e.g., all of it) in addition to around the spacer 1372. In someembodiments, the spacer 1372 can be positioned within the film 1372 suchthat the flow path between the first and second openings 1374 a, 1374 bonly flows through the spacer. In some embodiments, the spacer 1372 canbe disposed in the flow path to inhibit its occlusion. The secondopening 1374 b of the connector 1376 can be open to the environment 1390outside the wound dressing to which the pump 1304 is integrated. Thefirst opening 1374 a of the film 1374 can connect to a pump or one ormore other exhaust system 1370 features and components. In someembodiments, the first opening 1374 a can be positioned on the top ofthe film 1374. In some embodiments, the first opening 1374 a can bepositioned through an edge of the film 1374.

In some embodiments, the exhaust system 1370 can optionally include anextension conduit 1380 having any suitable length. The extension conduit1380 can be used to connect the connector 1376 to a source of negativepressure, such as, for example, the outlet 1304 b of the pump 1304.Although not shown in FIG. 31A, the length of the extension conduit 1380can advantageously position the connector 1376 outside of the wounddressing. A first end 1380 a of the extension conduit 1380 can becoupled to the first opening 1374 a of the film 1374. In someembodiments, a portion of the extension conduit 1380 can extend (alsoreferred to as inserted) into the connector 1376 through the firstopening 1374 a before being attached to the connector 1376 toadvantageously strengthen the attachment between the connector 1376 andthe extension conduit 1380. In some embodiments, a portion of theextension conduit 1380 can extend into the connector 1376 and beintegrated with the spacer 1372 (e.g., embedded with the spacer 1372).In some embodiments, a portion of the extension conduit 1380 can beenclosed in the spacer 1372. A second end 1380 b of the extensionconduit 1380 can be coupled to the outlet 1304 b of the pump 1304 tocomplete the flow path through the exhaust system 1370. Once theextension conduit 1380 is connected to the pump 1304 and the connector1376 is connected to the extension conduit 1380, the flow path of theexhaust system 1370 can be complete.

In some embodiments, the exhaust system 1370 does not include theoptional extension conduit 1380. In such embodiments, the connector 1376can be connected to the outlet 1304 b of the pump 1304 such that theflow path of the exhaust system 1370 includes the flow path through theconnector 1376.

As discussed above, the spacer 1372 can advantageously inhibit occlusionof the connector 1376. The arrangement of the connector 1376 can alsoadvantageously prevent ingress of water, foreign bodies, dirt, and/orbacteria from getting inside the wound dressing through the flow path ofthe connector 1376.

The exhaust system 1370 can pass through any suitable location on awound dressing through an opening in the wound dressing. For example, insome embodiments, a portion of the exhaust system 1370 can pass througha top layer of the wound dressing. As another example, in someembodiments, a portion of the exhaust system 1370 can pass through anedge of the wound dressing (e.g., a border of the wound dressing), suchas, for example, between a top layer and a bottom layer of the wounddressing. For example, FIG. 33C is a schematic side view of an end ofthe exhaust system 1370 between a top layer and a bottom layer of thewound dressing. In some embodiments, the end of the exhaust systembetween the top and bottom layers can be the connector 1376. In someembodiments, the end of the exhaust system between the top and bottomlayers can be the extension conduit 1380. In some embodiments, the toplayer can include a moisture vapor permeable film and the bottom layercan include a wound contact layer, although any suitable top and bottomlayers are appreciated. The exhaust system 1370 can form a gas tightseal where it passes through the opening in the wound dressing toadvantageously prevent the ingress of water, foreign bodies, dirt,and/or bacteria into the wound dressing.

In some embodiments, the exhaust system 1370 include one or moreconnectors 1376 and zero or more extension conduits 1380.

FIG. 31B is a perspective view of the exhaust system 1370 of FIG. 28Ashown coupled to an outlet of a pump, according to some embodiments.Unless otherwise noted, reference numerals and like-named components inFIG. 31B refer to components that are the same as or generally similarto the components of FIGS. 28A and 31A. FIG. 31B is similar to FIG. 31Aexcept a compression source 1385 is clamped to the connector 1376 andthe connector 1376 and the extension conduit 1380 have a differentarrangement. The compression source 1385 is shown clamped to theconnector 1376 to illustrate that the connector 1376 can resist acompression force. The clamp 1385 can be representative, for example, ofa patient lying on the connector 1376. In some embodiments, the clampingof the connector 1376, such as with the clamp 1385, can advantageouslyresult in no more than about a 17.5% reduction in flow rate.

As shown in FIG. 31B, in some embodiments, a portion of the extensionconduit 1380 can be enveloped by the film 1374. For example, in someembodiments, a distal portion 1380 c of the extension conduit 1380 canbe embedded within the film 1374. In some embodiments, a portion of theextension conduit 1380 can extend into the connector 1376 and attach toa portion of the spacer 1372. In some embodiments, a portion of theextension conduit 1380 can extend into the connector 1376 and beintegrated with a portion of the spacer 1372 (e.g., embedded with thespacer 1372). In some embodiments, a proximal portion 1380 d of theextension conduit 1380 can be covered by one or more connectors,filters, dampeners, and/or insulators 1387.

In yet other embodiments, a portion of the extension conduit 1380 (e.g.,an end of the extension conduit 1380) can attach to an edge 1374 c ofthe film 1374. In some embodiments, the edge 1374 c can include thefirst opening 1374 a of the film 1374 as described above with referenceto FIG. 31A. In such embodiments, reference numeral 1380 c can insteadrefer to a flow path defined by the film 1374 instead of a distalportion 1380 c of the extension conduit 1380. In such embodiments, theflow path defined by the film 1374 c can open into the region of theconnector 1376 containing the spacer 1372.

FIGS. 32A and 32B illustrates a wound dressing system with components ofthe wound dressing system illustrated in FIGS. 18 and 23 , respectively.Unless otherwise noted, reference numerals and like-named components inFIGS. 32A and 32B refer to components that are the same as or generallysimilar to the components of FIGS. 18 and 23 , respectively. FIG. 32Ashows the dressing with a portion of the top or first spacer layer 1317over the electronic area folded back and exposing underlying spacerlayer 1351 in the electronics area and the electronic components 1350.The exhaust system 1370 is shown coupled to the pump 1304 with theoptional extension conduit 1380. In FIG. 32A, the length of theextension conduit 1380 has lengthened the exhaust system 1370 such thatthe connector 1376 is positioned outside of the wound dressing.

FIG. 32B shows the wound dressing with the electronic components 1350exposed and the recessed spacer layers removed. FIG. 32B is similar toFIG. 32A except that the exhaust system 1370 in FIG. 32B does notinclude the optional extension conduit 1380. The exhaust system 1370 ofFIG. 32B is coupled to the pump 1304 with the connector 1376.

FIG. 33A is a close up view of the connector 1376 and the extensionconduit 1370 of FIG. 31B. Unless otherwise noted, reference numerals andlike-named components in FIG. 33A refer to components that are the sameas or generally similar to the components of FIGS. 28A and 31A-32B. Insome embodiments, the extension conduit 1380 can include one or moreribs 1383, which can act to secure the distal portion of the extensionconduit 1380 c between top and bottom layers of the film 1374 (or in anyother suitable fashion). In some embodiments, the one or more ribs 1383can be circular in shape, although any suitable shape is appreciated.The one or more ribs 1383 can be formed in the extension conduit 1380 bygrooves in a mold during the manufacturing of the extension conduit1380. During thermal bonding of top and bottom layers of the film 1374,for example, melted material from the top and bottom layers can flowaround the one or more ribs 1383, advantageously providing a strongerconnection between the extension conduit 1380 and the film 1374. As aresult, it may be more difficult to dislodge the extension conduit 1380out from the film 1374 during use of the exhaust system 1370. FIG. 33Aalso shows that the top and bottom layers of the film 1374 can be joinedtogether so that the film 1374 defines a chamber 1378. The chamber 1378can house the spacer 1372. In some embodiments, the spacer 1372 canoptionally include a fold 1373. The fold 1373 of the spacer 1372 canmake the end of the connector 1376 softer and therefore more comfortablefor a patient, and can also help prevent the extension conduit 1380 fromblockage. The fold 1373 can further protect the end of the extensionconduit 1380 (e.g., the first end of the extension conduit 1380 a) frombeing occluded by the top or bottom layers of the film 1374. The fold1373 can, in some embodiments, be between 1 cm and 3 cm (or betweenabout 1 cm and about 3 cm) long, and in some embodiments is 2 cm (orabout 2 cm) long. The spacer 1372 can be folded underneath itself, thatis toward a bottom layer of the film 1374, and in some embodiments canbe folded upward toward a top layer of the film 1374. In someembodiments, the spacer 1372 may contain no fold.

FIG. 33B is a perspective exploded view the exhaust system 1370 of FIG.33A. As shown in FIG. 33B, the film 1374 can include a top layer 1393and a bottom layer 1392. In some embodiments, the extension conduit 1380can optionally include one or more connectors, filters, dampeners,and/or insulators 1387. In some embodiments, a slot (also referred to asa channel) 1391 can extend perpendicularly away from the proximal end ofthe fold 1373, and the extension conduit 1380 can rest in the slot 1391.In some embodiments, the slot 1391 can extend through one layer of thefold, and in others it can extend through both layers of the fold. Theslot 1391 can, in some embodiments, be 1 cm (or about 1 cm) long. Someembodiments can instead employ a circular or elliptical hole in the fold1373. The hole may face proximally so that the extension conduit 1380can be inserted into the hole and rest between the folded layers of thespacer 1372. In some embodiments, the extension conduit 1380 can beadhered to the material of the fold 1383, while in other embodiments itmay not.

In some embodiments, a portion of the connector 1376 and/or theextension conduit 1380 (e.g., the top and/or bottom layers 1393, 1392 ofthe film 1374) can include a layer of adhesive, for example a pressuresensitive adhesive, to seal the exhaust system 1370 (e.g., a portion ofthe exhaust conduit 1380 and/or a portion of the connector 1376) to awound dressing. For example, in some embodiments, the connector 1376 canbe sealed to one or more layers of the wound dressing (e.g., the coverlayer, the wound contact layer, and the like).

In some embodiments, the top layer 1393 of the film 1374 can besubstantially the same shape as the bottom layer 1392 of the film 1374.In some embodiments, the top layer 1393 and the bottom layer 1392 can besealed together, for example, by heat welding and/or thermal bonding. Insome embodiments, the bottom layer 1392 can be substantially flat andthe top layer 1393 can be slightly larger than the bottom layer 1392 inorder to accommodate the height of the spacer 1372 and seal to thebottom layer 1392. In other embodiments, the top layer 1393 and thebottom layer 1392 can be substantially the same size, and the layers canbe sealed together approximately at the middle of the height of thespacer 1372. In some embodiments, the exhaust system 1370 can have alength in the range of about 0.3 cm to about 10 cm, although anysuitable length is appreciated. In some embodiments, the bottom and toplayers 1392, 1393 of the film 1374 can include at least one layer of aflexible film, and in some embodiments can be transparent. In someembodiments, the bottom layer 1392 and the top layer 1393 can bepolyurethane, and can be liquid impermeable.

As described above, the connector 1376 can include a spacer 1372, suchas the 3D fabric discussed above, positioned between the lower layer1392 and the top layer 1393 of the film 1374. The spacer 1372 can bemade of any suitable material, for example material resistant tocollapsing in at least one direction, thereby enabling effectivetransmission of exhaust air therethrough. Instead of or in addition tothe 3D fabric discussed above, some embodiments of the spacer 1372 cancomprise a fabric configured for lateral wicking of fluid, which maycomprise viscose, polyester, polypropylene, cellulose, or a combinationof some or all of these, and the material may be needle-punched. Someembodiments of the spacer 1372 can comprise polyethylene in the range of40-160 grams per square meter (gsm) (or about 40 to about 160 gsm), forexample 80 (or about 80) gsm. Such materials may be constructed so as toresist compression.

As shown in FIG. 28A, the wound dressing system 1300 can include anon-return valve 1410 to inhibit the back flow (also referred to as backleakage) of air into the wound dressing system 1300. For example, insome embodiments, the non-return valve 1410 can inhibit the back flow ofair (e.g., from the environment) into the wound dressing system 1300through the pump 1304. As described in more detail below, the non-returnvalve 1410 can allow fluid flow in a first direction but inhibit fluidflow in a second direction, such as, for example, a second directionopposite the first direction, although any two directions areappreciated. In some embodiments, the non-return valve 1410 can befluidically coupled to a portion of a flow path which extends between anoutlet of the pump 1304 and the environment. Such an arrangement canadvantageously allow the wound dressing system 1300 to deliver a morestable target pressure to a wound site by inhibiting back flow thatwould otherwise cause the target pressure to be more varied. Anon-return valve 1410 in fluid communication with the outlet of the pump1304 can also advantageously make the pump more efficient by reducingthe amount of power the pump consumes while it is drawing down and/ormaintaining the dressing at a given target pressure.

As shown in FIG. 28A, in some embodiments, the flow path between theoutlet of the pump 1304 and the environment can include an exhaustsystem 1370 to exhaust air from the pump 1304 to the outside of thewound dressing 1302 (e.g., to the environment). The non-return valve1410 can be, for example, positioned in the flow path between the pump1304 and the exhaust system 1370, although it should be appreciated thatthe non-return valve 1410 can be positioned in any suitable portion ofthe flow path that extends between the pump 1304 and the environment.For example, in some embodiments, the non-return valve 1410 can bepositioned on the inlet side of the pump between the wound dressing 1302and an inlet to the pump 1304. The exhaust system 1370 can be similar tothe exhaust system described in detail herein with reference to FIGS.31A-33C. In some embodiments, the non-return valve 1410 can beoptionally connected to the pump 1304 and/or the exhaust system 1370.The non-return valve 1410 can be, for example, fitted (also referred toas connected or coupled) to the outlet of the pump 1304 and/or at leastpartially disposed in the pump 1304 (e.g., the outlet of the pump 1304).Although not shown in FIG. 28A, in some embodiments, the non-returnvalve 1410 can optionally be integrated with the exhaust system 1370.For example, in some embodiments, the non-return valve 1410 can bepositioned at the inlet or outlet of the exhaust system 1370 or beincorporated within it. As another example, in some embodiments, thewound dressing system 1300 may optionally not include the exhaust system1370 altogether.

In some embodiments, the non-return valve 1410 can optionally beintegrated with the wound dressing 1302 and/or with one or more embeddedelectronic components 1350 (e.g., the pump 1304). The non-return valve1410 can be, for example, sufficiently small to fit within thedimensional constraints of the wound dressing 1302. In some embodiments,the non-return valve 1410 can be optionally positioned within and/orembedded in the wound dressing 1302, such as, for example, in theelectronics area 1361. To fit within the wound dressing 1302, thenon-return valve 1410 can have any suitable size and shape. For example,in some embodiments, the non-return valve 1410 can have a height that isless than a thickness of the wound dressing 1302 (e.g., a thicknessbetween the cover layer 1313 and the wound contact layer 1310). Asanother example, in some embodiments, the non-return valve 1410 can havea length that is less than a length of the electronics area 1361 of thewound dressing 1302.

So that the non-return valve 1410 can inhibit back flow while alsoefficiently allowing for out flow through the wound dressing system1300, the non-return valve 1410 can advantageously have a low crackingpressure and a low resistance to out flow. A low cracking pressure and alow resistance to out flow can advantageously decrease the amount ofpower consumed during operation of the pump 1304 by decreasing theamount of resistance the pump 1304 must overcome to exhaust air. The useof a non-return valve 1410 can decrease the leak rate (also referred toas back flow) of the wound dressing system 1300 more than it decreasesthe pump rate of the wound dressing system 1300. For example, in someembodiments, using the non-return valve 1410 can result in a total leakrate reduction of about 8.4% compared to a total pump rate reduction ofabout 7%, thereby resulting in an energy savings of approximately 1.4%from the use of the non-return valve 1410 alone. In some embodiments,the cracking pressure of the non-return valve 1410 can range from about350 Pa to 500 Pa for a flow rate of about 1 mL/min (e.g., a flow rate ofexactly 1 mL/min), although any suitable cracking pressure isappreciated (and at any suitable flow rate), such as, for example, about100 Pa, 250 Pa, 400 Pa, 550 Pa, or less than about 1,000 Pa for flowrates of about 1 mL/min, among others (e.g., any suitable crackingpressure between 0 Pa and 1,000 Pa). The cracking pressure according theaforementioned values corresponds to the threshold pressure drop to openand reseal of the non-return valve 1410 for air flows having rate ofabout 1 mL/min. It should be appreciated that any other standardizedflow rates can be used as well. In some embodiments, the non-returnvalve 1410 may not decrease the flow rate through the pump by more than100 mL/min. For example, in some embodiments, the non-return valve 1410can decrease the flow rate through the pump between approximately 9.5mL/min and approximately 24.5 mL/min, although other values of 100mL/min or less are also appreciated. In some embodiments, the non-returnvalve 1410 can have an out flow resistance in the range of about 5.0mL/min to about 30 mL/min (measured with a nominally fixed vacuum of10.7 kPa below atmosphere), although any suitable out flow resistance isappreciated, such as, for example, an out flow resistance of about 9.5mL/min to about 24.5 mL/min, an out flow resistance of about 9.5 mL/min,an out flow resistance of about 14.6 mL/min, an out flow resistance ofabout 24.5 mL/min, and an out flow resistance of less than about 100mL/min, among others (as measured with a nominally fixed vacuum of 10.7kPa below atmosphere). In some embodiments, the non-return valve 1410does not prevent all back flow. For example, in some embodiments, thenon-return valve 1410 can allow a negligible amount of air to leak intothe wound dressing system 1300 through the outlet of the pump 1304. Forexample, in some embodiments, the leakage rate of the non-return valve1410 can be negligible such that the pump 1304 and the non-return valve1410 have a combined leak rate of about 10.0 mL/min or less, such as,for example, 1.0 mL/min or less, 2.0 mL/min or less, 3.0 mL/min or less,4.0 mL/min or less, or 5.0 mL/min or less. In some embodiments, thewound dressing system 1300 can establish a target vacuum in 50 secondsor less with a non-return valve 1410 incorporated with the wounddressing 1302 and/or the exhaust system 1370. For example, in someembodiments, the wound dressing system 1300 can establish a targetvacuum in about 5.1 seconds to 8.9 seconds, although any suitable timeis appreciated.

The non-return valve 1410 positioned in the out flow path of the wounddressing system 1300 can be a mechanical self-activated valve that doesnot need and/or use power to operate. For example, in some embodiments,the non-return valve 1410 can be a reed valve or a duckbill valve,although any suitable mechanical one-way valve is appreciated, such as,for example, a ball valve or an umbrella valve, among others. Variousviews of duckbill non-return valves 1410 are illustrated in FIGS.34A-34D, with FIGS. 34C and 34D showing the duckbill valve 1410 coupledto a pump outlet 1304 b. FIGS. 35A-35C illustrate various views ofvarious reed valves 1410 coupled to a pump outlet 1304 b. For example,FIG. 35A shows a reed valve 1410 having a cavity 1434 with an inlet port1432 and an outlet port 1436 and a reed 1438 at least partially disposedin the cavity 1434. The reed 1438 of the reed valve 1410 can occlude theflow path between the pump 1304 and the environment such that it allowsfluid flow in a first direction (e.g., away from the pump) but inhibitsfluid flow in a second direction (e.g., toward the pump). For example,in some embodiments, the reed 1438 can act as an encastered beam, withone end fixed and another end free to deflect. The sensitivity of thereed 1438 can be increased by increasing its length (i.e., longer reedscan be more sensitive than shorter reeds). For example, all else beingequal, longer reeds can have lower cracking pressures and lower out flowresistances. In some embodiments, the reed 1438 can have a length in therange of about 3.0 mm to about 30 mm (e.g., as measured from the centerof the non-return valve hole is seals to its opposite end). For example,in some embodiments, the reed 1438 has a length of about 10.5 mm,although any suitable length is appreciated. In some embodiments, thereed valve 1410 can be a 75 micron thick polyester reed valve, althoughany suitable thickness and material is appreciated.

As shown in FIGS. 35A-35C, the shape of the non-return valve 1410 can berectangular with two rounded ends. However, it will be understood thatother suitable shapes can be provided. For example, FIGS. 36A-36Cillustrate various views of a non-return valve 1410 having a crescentshape that can advantageously facilitate integration of the non-returnvalve 1410 into a wound dressing (e.g., wound dressing 1302 shown inFIG. 28A). For example, the crescent shape can advantageously reduce thesize of the non-return valve 1410 and make the wound dressing system1300 more compact. As another example, the crescent shape canadvantageously facilitate the attachment of the top surface 1440 a to acover layer (not shown, but see cover layer 1313 in FIG. 28A). Forexample, the curved top surface 1440 a of the crescent shape can helpachieve a seal with the cover layer. The crescent shape can alsoadvantageously streamline the upper surface of the wound dressing systemin which it is incorporated by softening the edges of the non-returnvalve, thereby making the wound dressing system more comfortable to theuser and at the same time making it less bulky. The upper curved surface1440 a of the non-return valve 1410 can also reduce the likelihood ofthe non-return valve 1410 from becoming snagged by better deflectingobjects that come into contact with it. Note that unless otherwisespecified, reference numerals in FIGS. 36A-36C refer to components thatare the same as or generally similar to the components of FIGS. 28A and34A-35C. FIGS. 36B and 36C further illustrate a crescent shapednon-return valve 1410 positioned adjacent a pump 1304. In someembodiments, the inlet port 1432 of the non-return valve can be coupledto the pump outlet 1304 b.

Further, although FIGS. 36B and 36C illustrate a non-return valve 1410having a crescent shape with an upper curved surface which intersects alower flat surface, any suitable crescent shape is appreciated. Forexample, in some embodiments, the lower flat surface can have a curvewhich conforms to the surface of a wound site. In such embodiments, theradius of curvature of the upper surface can be less than the radius ofcurvature of the lower surface so that the two surfaces intersect. Insome embodiments, the housing of the non-return valve 1410 can be madeof a rigid, semi-rigid, and/or flexible material. For example, in someembodiments, the upper and lower surfaces of the non-return valve can besemi-rigid. As another example, in some embodiments, the lower surfaceof the non-return valve 1410 can be less rigid than the upper surface sothat the lower surface can better conform to the surface of a woundsite. The non-return valve 1410 can be made from any suitable material.In addition, for non-return valve embodiments including a reed, the reedcan have a curved portion that fits inside the crescent shape of thenon-return valve 1410 housing to advantageously make the non-returnvalve 1410 more compact.

Although not shown in FIGS. 34A-36C, the non-return valve 1410 can bepositioned between the wound contact layer and the cover layer such thata bottom surface of the non-return valve 1410 sits on the wound contactlayer and a top surface of the non-return valve 1410 sits under thecover layer (e.g., wound contact layer 1310 and cover layer 1313 in FIG.28A). In some embodiments, the non-return valve 1410 can be sealed tothe wound dressing 1302 and/or the exhaust system 1370 with an oil seal.

FIG. 37 illustrates a crescent shaped non-return valve 1410 positionedsuperficially above an exhaust system 1370 and a wound dressing 1302. Asdescribed above, in some embodiments, the non-return valve 1410 can beintegrated with the exhaust system 1370 and be positioned between thewound contact layer 1310 and the cover layer 1313. In some embodiments,the inlet port 1432 of the non-return valve 1410 can be fluidicallycoupled to the outlet of the pump (not shown) and the outlet port 1436of the non-return valve 1410 can be fluidically coupled to an inlet ofthe exhaust system 1370 (not shown). In some embodiments, the non-returnvalve 1410 can be integrated with the exhaust system 1370 beyond theborder of the wound dressing 1302 (i.e., external to the wound dressing1302).

FIGS. 38A-38E illustrate various positions of a non-return valve 1410 inrelation to a pump 1304 and an exhaust system 1370. FIG. 38A illustratesa non-return valve 1410 positioned between a pump 1304 and an exhaustsystem 1370. For example, in some embodiments, the non-return valve 1410can be fluidically coupled to an outlet of the pump 1304 and an inlet ofthe exhaust system 1370. In some embodiments, the non-return valve 1410can be fluidically coupled to an outlet of the exhaust system (e.g., sothat the exhaust system 1370 is interposed between the non-return valve1410 and the pump 1304). FIG. 38B illustrates a non-return valve 1410positioned after an exhaust system 1370. For example, in someembodiments, the non-return valve 1410 can be fluidically coupled to anoutlet of the exhaust system 1370. FIG. 38C illustrates a non-returnvalve 1410 positioned between an inlet (not labeled) and a pump 1304.For example, in some embodiments, the non-return valve 1410 can befluidically coupled to an inlet of the wound dressing and an inlet ofthe pump 1304. As another example, FIG. 38C illustrates a non-returnvalve 1410 integrated with an inlet of a pump 1304. FIG. 38D illustratesa non-return valve 1410 positioned after a pump 1304 and integrated withan outlet of an exhaust system 1370. FIG. 38E illustrates a non-returnvalve 1410 positioned after a pump 1304 and integrated with an inlet ofan exhaust system 1370. The non-return valves 1410 illustrated in FIGS.38A-38E are shown as having a rectangular shape with circular ends.However, it will be understood that the non-return valves 1410 in FIGS.38A-38E can have any suitable shape, such as, for example, a crescentshape, among any other suitable shape. The non-return valve 1410 and/orthe exhaust system 1370 in FIGS. 38A, 38B, 38D, and 38E can be wholly orpartially positioned within or external to a dressing border (notshown). A portion of the non-return valve 1410 and/or the exhaust system1370 in FIGS. 38A, 38B, 38D, and 38E can be wholly or partiallyintegrated within a wound dressing (not shown). In some embodiments, thepump inlet can include a fluid ingress inhibition component in fluidcommunication with the pump. The component can allow gas (e.g., air) butinhibit liquid (e.g., wound exudate) from passing through. The componentcan provide a plurality of flow paths between an interior of the wounddressing 1302 and the pump 1304 so that occlusion (e.g., from woundexudate) of the pump 1304 is inhibited. Examples of such applicationswhere additional disclosure relating to the preceding may be foundinclude U.S. Provisional Application No. 62/327,676, titled “FluidIngress Inhibition Component for Reduced Pressure Apparatuses,” filed onApr. 26, 2016, the disclosure of which is hereby incorporated byreference in its entirety.

FIGS. 39A and 39B illustrate two positions of a crescent-shapednon-return valve 1410 in relation to an exhaust system 1370. FIG. 39Aillustrates a non-return valve 1410 having a crescent shape integratedwith an exhaust system 1370. For example, in some embodiments, thenon-return valve 1410 can be fluidically coupled and integrated with anexhaust system 1370 somewhere between an inlet and an outlet of theexhaust system 1370. FIG. 39B illustrates a non-return valve 1410 havinga crescent shape positioned after a pump (not shown) and integrated withan outlet of an exhaust system 1370. For example, in some embodiments,the exhaust system 1370 can be fluidically coupled to an outlet 1304 bof the pump. The non-return valves 1410 illustrated in FIGS. 39A-39B areshown as having a crescent shape. However, it will be understood thatthe non-return valves 1410 in FIGS. 39A-39B can have any suitable shape,such as, for example, a rectangular shape with circular ends, among anyother suitable shape.

All of the features disclosed in this specification (including anyaccompanying exhibits, claims, abstract and drawings), and/or all of thesteps of any method or process so disclosed, may be combined in anycombination, except combinations where at least some of such featuresand/or steps are mutually exclusive. The disclosure is not restricted tothe details of any foregoing embodiments. The disclosure extends to anynovel one, or any novel combination, of the features disclosed in thisspecification (including any accompanying claims, abstract anddrawings), or to any novel one, or any novel combination, of the stepsof any method or process so disclosed.

Various modifications to the implementations described in thisdisclosure may be readily apparent to those skilled in the art, and thegeneric principles defined herein may be applied to otherimplementations without departing from the spirit or scope of thisdisclosure. Thus, the disclosure is not intended to be limited to theimplementations shown herein, but is to be accorded the widest scopeconsistent with the principles and features disclosed herein. Certainembodiments of the disclosure are encompassed in the claim set listedbelow or presented in the future.

1. A wound dressing apparatus comprising: a wound contact layerconfigured to be positioned in contact with a wound; a first area overthe wound contact layer comprising: a lower spacer layer; an absorbentlayer; a second area over the wound contact layer comprising a pluralityof spacer layers and a negative pressure source and/or electroniccomponents positioned within or between the plurality of spacer layers,wherein the first area is positioned adjacent to the second area andseparated by a partition; an upper spacer layer configured to cover thefirst area and the second area and to allow air to be communicatedbetween the first area and second area around the partition; and a coverlayer configured to cover and form a seal over the wound contact layer,the upper spacer layer, the first area, and the second area.
 2. Thewound dressing apparatus of claim 1, wherein the plurality of spacerlayers in the second area comprise a third spacer layer beneath thenegative pressure source and/or electronic components and a fourthspacer layer positioned above the negative pressure source and/orelectronic components, wherein the fourth spacer layer comprises one ormore cutouts or recesses configured to receive the negative pressuresource and/or electronic components.
 3. The wound dressing apparatus ofclaim 1, wherein the partition comprises a non-porous dam.
 4. The wounddressing apparatus of claim 1, further comprising one or more userinterface components configured to allow a user to operate the negativepressure source and/or electronic components.
 5. A wound dressingapparatus comprising: a wound dressing configured to be positioned overa wound site; a negative pressure source disposed on or positionedwithin the wound dressing; and a switch integrated with the wounddressing configured to control operation of the wound dressingapparatus. 6.-27. (canceled)
 28. A wound dressing apparatus comprising:a wound dressing configured to be positioned over a wound site; anegative pressure source disposed on or positioned within the wounddressing, the negative pressure source comprising an inlet and anoutlet, the negative pressure source being configured to apply negativepressure to the wound site via the inlet and being further configured toremove air from the wound dressing via the outlet; and a connectorcomprising first and second ends and a flow path therebetween, whereinthe first end is in fluid communication with the outlet and the secondend is open to an environment outside the wound dressing, wherein aportion of the flow path extends through an opening defined in the wounddressing, the flow path being configured to direct air from the outletto the environment. 29.-77. (canceled)